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 As in many developing countries, the Drug Regulatory Authority of
Pakistan (DRAP) sets prices for about 320 critical medicines. But
pricing caps have not been significantly raised since 2001, making
it unviable for firms to make many of the drugs.
The issue has become particularly acute for TB drugs. Of 18
companies licensed to manufacture TB drugs in Pakistan, only four,
including Novartis, were making them this year, said Ayesha Haq,
executive director of Pharma Bureau, a trade group representing 20
firms in Pakistan.
Doctors and public health officials said shortages could lead to a
rise in drug-resistant strains of TB with tens of thousands of
patients missing doses mid-treatment. The drugs include combinations
of antibiotics as well as substitutes for patients with
complications.
"It's an emergency in the making," said Naseem Salahuddin, an
infectious disease doctor in Karachi.
With a population of 190 million, Pakistan has around 500,000 TB
patients every year, according to the World Health Organization.
Rana Iftikhar Anjum, a resident of Multan in Punjab province, said
it took him weeks to track down TB drugs for his 15-year-old niece,
and Muhammad Rafiq, a pharmacist at a leading Islamabad hospital,
said he had to pay 2,000 rupees ($19) in bribes to get the drugs for
his brother, who suffers from multi-drug resistant TB, from a
government hospital.
RECOMMENDED WORKAROUND
Novartis spokesman Dermot Doherty said the company, which controls
around 30 percent of Pakistan's TB drug market, was looking to exit
the business, and Ahsan Raees, in charge of the company's regulatory
affairs in Pakistan, blamed the production halt on the price
dispute. "If they had given us the price increase, we would never
have done this," he said.
Pfizer Inc, which controls another 30 percent of the market, has
also seen supply disruptions in recent months, adding to shortages,
spokeswoman Trupti Wagh said. She did not elaborate on the
disruptions, but said they were resolved last month. She declined to
say whether the pricing dispute was a factor.
A local TB drug maker, Schazoo Zaka, also partially cut production
because of the pricing dispute, said Ejaz Qadeer, who heads
Pakistan's anti-TB program. Schazoo Zaka did not respond to a
request for comment.
While TB medicine is available in government hospitals, at least a
third of patients rely on private clinics, where the drugs are hard
to come by, health officials and patients said.
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DRAP Chief Executive Muhammad Aslam said he has recommended a
workaround to the health ministry for companies to raise prices for
some critical medicines, and a decision could come next month.
PRICING POLICY
Pakistan has raised critical drugs prices on an ad hoc basis over
the past 15 years when companies have asked, but drugs firms say
those increases have not been enough. Haq, the lobbyist, said
companies were seeking an average 30 percent increase for regulated
drugs to make production viable.
Formed in 2012 to oversee drug regulation, DRAP this month
instituted a first annual price increase since 2001, with increases
pegged to inflation, which last year was at a 46-year low of 2.86
percent.
Last month, DRAP also allowed for an 8 percent increase in TB drug
prices under a hardship clause, which drug companies can apply for
once every three years.
DRAP's Aslam acknowledged that price increases so far were not
enough.
About 18 months ago, DRAP recommended that at least three dozen
drugs be put under a new 'orphan drug' policy - for medicines
developed to treat rare diseases, and typically with no price cap,
so as to give manufacturers an incentive to produce for a small
market.
"Anti-TB drugs, cardiac drugs, anti-cancer drugs - these are
critically needed," Aslam said.
TB is not classified as a rare disease in Pakistan, but listing it
as an orphan disease would allow companies to get around current
regulations and sell TB drugs at cost price.
Sajid Hussain Shah, a ministry spokesman, said work was ongoing on
the policy.
(Writing by Asad Hashim; Editing by Paritosh Bansal and Ian
Geoghegan)
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